Natriuretic Peptide Concentrations of B-type (BNP) During Anesthesia in Patients Previously Sensitized to Anthracyclines

NCT01754597 | Completed Results DMC

• 1 other identifier: IB2009-39
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The cardiotoxicity of anthracyclines chemotherapy remains a major problem, despite clinical and echocardiographic monitoring. In the case of treatment for breast cancer, surgery requiring general anesthesia may follow chemotherapy. Although a possible interaction between general anesthetics and anthracyclines on systolic function is only rarely mentioned, some cases of heart failure and / or conduction disturbances peranesthésique were observed in patients treated or previously treated with anthracyclines. The determination of concentration of BNP is a diagnostic tool used in the detection of heart failure and acute coronary syndromes. The question of a possible synergism between cardiotoxic anthracyclines and anesthetic agents arises. Given its minimally invasive nature and its diagnostic value, the BNP assay might thus allow to highlight a possible subclinical deficiency. To our knowledge, there is very little data regarding a possible synergism between cardiotoxic anthracyclines and anesthetic agents.

Conditions

Breast Cancer

Keywords

Anesthesia

Outcome Measures

Primary Outcomes (3)

• Pre-operative Concentration of NT-proBNP

  Mean concentration of NT-proBNP measured before surgery.

  Before breast surgery

• Concentration of NT-proBNP at the End of Intervention

  Mean concentration of NT-proBNP measured at the end of intervention

  At the end of breast surgery

• Post-operative Concentration of NT-proBNP

  Mean concentration of NT-proBNP measured 24 hours after breast surgery

  24 hours after breast surgery

Study Arms (2)

Participants not previously treated with anthracyclines

OTHER

No anthracycline treatment in the 6 months prior to inclusion.

Other: Dosage of B-type natriuretic peptide (NT-proBNP)

Participants previously treated with anthracyclines

OTHER

Other: Dosage of B-type natriuretic peptide (NT-proBNP)

Interventions

Dosage of B-type natriuretic peptide (NT-proBNP) OTHER

NT-proBNP concentration assessed at the following time points : * T0: before induction of general anesthesia, NT-proBNP measurement * T1: 30 minutes after induction of general anesthesia * T2: at the end of the procedure * T3: in the postoperative period, 6 hours after the end of the procedure * T4: in the postoperative period, 24 hours after the end of the procedure

Participants not previously treated with anthracyclines; Participants previously treated with anthracyclines

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women over 18 years with effective contraceptive method (if applicable)
• NT-proBNP \<125 pg / ml
• ASA 1 or 2,
• Breast cancer histologically proven
• Mastectomy or lumpectomy
• Neoadjuvant chemotherapy with anthracyclines in 6 months or received no chemotherapy with anthracyclines,
• Patients who received the briefing and signed the informed consent
• Patients affiliated to a social security system.

You may not qualify if:

• Patients for whom the maintenance of general anesthesia does not use halogenated.
• Renal impairment: Creatinine clearance \<60 ml / min,
• Patients who for reasons psychological, social, family or geographical could not be treated or monitored regularly according to the criteria of the study, patients deprived of liberty or under guardianship.
• Presence of a cardiopathy
• Pregnant Women

Sponsors & Collaborators

• Institut Bergonié: lead

Study Sites (1)

Institut Bergonié

Bordeaux, Aquitaine, 33000, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pro-brain natriuretic peptide (1-76)

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Simone Mathoulin-Pélissier, Director of Clinical Trials Unit
• Organization: Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR

s.mathoulin@bordeaux.unicancer.fr

+33 5 56 33 33 33

Study Officials

• GEKIERE Jean Pierre, MD

  Institut Bergonié

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This feasibility study will describe the evolution of NT-ProBNP during general anesthesia in patients undergoing surgery for breast cancer, depending on whether or not they have previously been treated with anthracyclines. The data collected in this study will be used later in a clinical trial comparing the occurrence of subclinical heart failure during breast cancer surgery under general anesthesia, depending on whether patients have been sensitized to anthracyclines.

Study Record Dates

• First Submitted: November 6, 2012
• First Posted: December 21, 2012
• Study Start: September 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 1, 2025
• Results First Posted: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)